NCT00904995

Brief Summary

Objectives: To investigate the relationship between the administration of intravenous (IV) and oral voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative to the standard assessment criteria used to diagnose invasive fungal infection in patients with hematologic malignancies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 12, 2011

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

May 18, 2009

Results QC Date

April 18, 2011

Last Update Submit

August 1, 2012

Conditions

LeukemiaFungal Infection

Keywords

LeukemiaCancer of the bloodCancer of the bone marrowHematologic malignancyInvasive fungal infectionVoriconazoleVfendantifungal prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Samples With BG Levels > 60pg/ml

    Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI). Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity.

    Up to 42 days

Study Arms (2)

Group 1 - Oral

EXPERIMENTAL

Voriconazole Starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.

Drug: Voriconazole

Group 2 - IV + Oral

EXPERIMENTAL

Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.

Drug: Voriconazole

Interventions

VoriconazoleDRUG

Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.

Also known as: Vfend
Group 1 - Oral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
  • Age \>/= 18 years.
  • Patients must sign an informed consent.

You may not qualify if:

  • Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole
  • Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (European Organisation for Research and Treatment of Cancer (EORTC) criteria).
  • Patients with total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT)\> 5 times upper limit normal.
  • Patients receiving any medication that is contraindicated with the use of voriconazole. Voriconazole is contraindicated with the co-administration of the following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h), carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and efavirenz), St. John's Wort.
  • Patients currently receiving voriconazole for antifungal prophylaxis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMycosesHematologic NeoplasmsInvasive Fungal Infections

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBacterial Infections and MycosesInfectionsNeoplasms by Site

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Jorge Cortes, MD / Professor
Organization
The University of Texas MD Anderson Cancer Center
eharrison@mdanderson.org
713-745-5783

Study Officials

  • Jorge Cortes, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 7, 2012

Results First Posted

May 12, 2011

Record last verified: 2012-08

Locations

US(1)